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Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

Primary Purpose

Shoulder Dystocia

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Yaari Extractor
Sponsored by
FetalEase Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Dystocia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Subject 18 years of age or older at time of consent. Subject planning on vaginal birth. Singleton pregnancy in vertex presentation. Full-term pregnancy having completed 37 weeks or more gestational weeks. Able and willing to provide written informed consent prior to enrollment. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF). Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery." Exclusion Criteria: Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Yaari Extractor. Cesarean section is planned for the patient. Obstetric contraindications to vaginal birth. Subject carrying fetus with known significant chromosomal or structural anomalies. Clinically estimated fetal weight ≥5kg in non-diabetic subjects. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc. Any maternal disease or disorder that precludes the subject from pushing effectively. If the maternal cervix is not fully dilated. If the fetal head is not completely out of the birth canal. In the presence of a non-reducible nuchal cord.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Yaari Extractor group

    Control group

    Arm Description

    Prospective experimental arm

    Historical control arm - retrospective review of medical records at the same study sites

    Outcomes

    Primary Outcome Measures

    Number of successful neonate deliveries with the Yaari Extractor device
    First Primary Effectiveness Endpoint
    Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
    Second Primary Effectiveness Endpoint
    Maternal and neonatal adverse events
    Primary Safety Endpoint

    Secondary Outcome Measures

    Ease of Use 5 point Likert scale User Questionnaire
    Secondary Effectiveness Endpoint

    Full Information

    First Posted
    June 8, 2023
    Last Updated
    June 21, 2023
    Sponsor
    FetalEase Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05913609
    Brief Title
    Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
    Official Title
    IDE Clinical Study to Evaluate the Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    June 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 2023 (Anticipated)
    Primary Completion Date
    September 2025 (Anticipated)
    Study Completion Date
    December 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    FetalEase Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    Yes
    Device Product Not Approved or Cleared by U.S. FDA
    Yes
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Prospective, multi-center, single arm with historical control, to verify the safety and effectiveness of the Yaari Extractor used by board certified or board eligible U.S. OB/GYN physicians in the management of shoulder dystocia.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Shoulder Dystocia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    80 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Yaari Extractor group
    Arm Type
    Experimental
    Arm Description
    Prospective experimental arm
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Historical control arm - retrospective review of medical records at the same study sites
    Intervention Type
    Device
    Intervention Name(s)
    Yaari Extractor
    Intervention Description
    The Yaari Extractor device is a single-use prescription device for neonatal extraction in deliveries that are complicated by shoulder dystocia. The Study Device consists of two curved, rigid plastic-coated metal Arms with Handles which are used for control of the device outside the body, and an elastic Engagement Element which conforms to the maternal and neonatal anatomy, and which is used for direct contact with the entrapped neonate within the birth canal.
    Primary Outcome Measure Information:
    Title
    Number of successful neonate deliveries with the Yaari Extractor device
    Description
    First Primary Effectiveness Endpoint
    Time Frame
    immediately after the intervention
    Title
    Time interval (minutes) from the diagnosis of the shoulder dystocia until the neonate's delivery
    Description
    Second Primary Effectiveness Endpoint
    Time Frame
    immediately after the intervention
    Title
    Maternal and neonatal adverse events
    Description
    Primary Safety Endpoint
    Time Frame
    through study completion, an average of 5 days
    Secondary Outcome Measure Information:
    Title
    Ease of Use 5 point Likert scale User Questionnaire
    Description
    Secondary Effectiveness Endpoint
    Time Frame
    immediately after the intervention

    10. Eligibility

    Sex
    Female
    Gender Based
    Yes
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Subject 18 years of age or older at time of consent. Subject planning on vaginal birth. Singleton pregnancy in vertex presentation. Full-term pregnancy having completed 37 weeks or more gestational weeks. Able and willing to provide written informed consent prior to enrollment. In the opinion of the Investigator, the subject has sufficient mental capacity to understand the informed consent form (ICF). Subject with fetus experiencing shoulder dystocia as defined by ACOG Practice Bulletin 178 "Shoulder dystocia is most commonly diagnosed as failure to deliver the fetal shoulder(s) with gentle downward traction on the fetal head, requiring additional maneuvers to effect delivery." Exclusion Criteria: Patients who have undergone ancillary standard of care maneuvers, to include first-line maneuvers (McRoberts/suprapubic pressure), prior to use of the Yaari Extractor. Cesarean section is planned for the patient. Obstetric contraindications to vaginal birth. Subject carrying fetus with known significant chromosomal or structural anomalies. Clinically estimated fetal weight ≥5kg in non-diabetic subjects. Clinically estimated fetal weight ≥4.5kg in subjects with diabetes. Subject has any general health condition or systemic disease that may represent, in the opinion of the Investigator, a potential increased risk associated with device use or pregnancy. Bleeding disorders, such as thrombocytopenia, von Willebrand's disease, bleeding disorder currently using anticoagulation medication, etc. Any maternal disease or disorder that precludes the subject from pushing effectively. If the maternal cervix is not fully dilated. If the fetal head is not completely out of the birth canal. In the presence of a non-reducible nuchal cord.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ahava Stein
    Phone
    +972522346927
    Email
    ahava@asteinrac.com

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Safety and Effectiveness of the Yaari Extractor for Management of Shoulder Dystocia

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